Vessel for processing a biopharmaceutical product including protection means

ABSTRACT

A vessel includes: a pocket capable of assuming a folded state and an expanded state, processing element including an active inner portion; protection element including a side wall, a lower portion and an upper portion defining an inner space, the lower portion being attached to the upper portion of the pocket, the active inner portion being provided in the inner space when the pocket is in the folded state, the peripheral portion of the inner space about the processing element defining a protection chamber; at least one insertion and/or draining opening. The active inner portion is provided inside the pocket adjacent to the lower end portion thereof, the processing element and the protection element are independent in terms of their movements, and the height of the protection chamber is variable and automatically adapts itself based on respectively, the flat-folded, unfolded and expanded states or any intermediate state of the pocket.

The invention relates to a biopharmaceutical product processingreceptacle. Its object is more particularly such a receptacle, aprocessing device that incorporates such a receptacle, and the processfor using such a receptacle.

“Biopharmaceutical product” is defined here as one (or more) product(s)obtained from biotechnology—culture media, cellular cultures, buffersolutions, artificial nutrition liquids, blood products, and derivativesof blood products—or a pharmaceutical product, or more generally aproduct that is designed to be used in the medical field. Such a productis in liquid, pasty or powder form, in one or more phases, homogeneousor not. The invention also applies to products other thanbiopharmaceutical products, according to the definition that was justgiven, but that are subject to analogous requirements relative to theirprocessing.

A pocket is known that is designed to accommodate such abiopharmaceutical product, which comprises a lower end wall, an upperend wall, and, between them, a flexible side wall that can be—in linewith the pocket itself—in two extreme states—a flat-folded state, and anexpanded, unfolded state—and can be deformed to switch from one of theseextreme states to the other or be in any intermediate state. The wallsof the pocket, made of plastic such as polyethylene or a complex thatcomprises polyethylene, define an inner space that, in the folded state,has a minimum and even zero or almost-zero volume, and, in the unfoldedand expanded state, has a maximum volume. This space is designed toaccommodate the biopharmaceutical product.

Such a pocket is designed either for simple storage of thebiopharmaceutical product or for specific processing, i.e., any actionon the product or relative to this product and involving contact withthe product, such as mixing, aeration, filtration, and measurement,whereby this list is not exhaustive. For this purpose, such a processingmeans that is suitable for the desired action, such as a mixingpropeller, aerator, filter, or probe is implemented, whereby this listis not exhaustive. Such a (or such) processing means is (are), at leastin part, placed actually inside the pocket by being adjacent to itslower portion (on it, close to it, or in its vicinity), so as to be ableto be in contact with the product.

The preceding constructive arrangements are not without risk. Actually,when the pocket is in the flat-folded state or in a slightly unfolded ornearly folded state or switches from one of these states to the other,there is a risk that the active inner portion of the processing meanswill interfere with the wall of the pocket, more particularly the wallof the upper end, and more or less significantly alter its integrity andits qualities by embrittling it, perforating it or tearing it.Furthermore, there is also a risk that the active inner portion of theprocessing means will interfere with exogenic elements that are outsideof the pocket (such as supports or other devices that are next to thepocket) and be more or less significantly altered, for example deformedor moved or else wedged.

These constructive arrangements exhibit another drawback, namely notallowing complete draining of the contents of the pocket. Actually, thepocket under the action of the reduction of pressure resulting fromdraining flattens against the active inner portion of the processingmeans with a serious risk of tearing, most often compensated for by notdraining the pocket completely.

The document WO 00/04131 describes a pocket with gussets having a sideportion, an upper portion, and a lower portion, designed to contain one(or more) such biopharmaceutical product(s), with a volume of 50 litersand more. Such a pocket can be found either in a flat-folded state forbeing stored empty or in an unfolded and expanded state where it has ageneral pallelepipedic shape when it contains a product. According tothe embodiments, such a pocket also comprises, in the upper portion, one(or several) opening(s) or connection(s) designed to allow its fillingand, in the lower portion, an outlet that is designed to allow it todrain.

The document U.S. Pat. No. 5,350,080 describes a system that comprises arigid outer container that supports a pocket that defines an innerstorage chamber whose access is possible through a filling port that islocated in the upper portion and a draining port that can be provided inthe lower portion. When the contents of the pocket are drained, theupper filling port is forced by its own weight toward the lower portionof the pocket. In the case where the inner portion of the filling porthas no tube, it can come into contact with the lower portion of thepocket, where there is the risk that it may become damaged and locked.Also, it is provided that the filling port comprises a side skirt whoseheight is greater than the length of the downward projection of theinner portion of the filling port, such that this inner portion ishoused entirely within the skirt and its lower end is always locatedabove the lower portion of the pocket, even when the skirt rests on thelatter.

The documents US 2007/0224676 and GB 2 080 756 describe receptacles thatcomprise an accordion-like flexible side wall, capable of being foldedor unfolded, and, on both sides of the latter, two end walls,respectively, lower and upper, whereby the latter is provided with anopening.

The object of the invention is to eliminate the above-mentioneddrawbacks that are linked to the presence of processing means arrangedin foldable pockets that can be arranged flat-folded.

For this purpose, and according to a first aspect, the object of theinvention is a processing receptacle for at least one biopharmaceuticalproduct, comprising:

-   -   A pocket that has a flexible side wall, a lower end portion, and        an upper end portion that define an inner space that is designed        to accommodate at least one product that can be in two extreme        states, flat-folded and expanded, and in any intermediate state,        and can be deformed to switch from one state to the other;    -   Means for processing at least one product that is contained in        the receiving space of the pocket, comprising an inner portion        of a certain height that is arranged inside the receptacle;    -   Protective means of the processing means, comprising a side        wall, a lower end portion and an upper end portion that define        an inner space communicating with the inner space of the pocket,        whose lower end portion is adjacent and attached rigidly to the        upper end portion of the pocket, the movement of the latter        upward or downward bringing about a movement of the protective        means, whereby the inner portion of the processing means is        essentially arranged in the inner space of the protective means        when the pocket is in the flat-folded state, the peripheral        portion of the inner space of the protective means around        processing means forming a protective chamber of the pocket and        processing means;    -   At least one opening for introducing at least one product into        the receptacle and/or for draining the contents from the        receptacle;        in which:    -   The processing means are at least partially—mixing element,        sensor, tube, aerating element, etc.—arranged inside the pocket        by being adjacent to its lower end portion;    -   The processing means and the protective means are arranged to be        independent from one another relative to their movements;    -   The variable height of the protective chamber can be one of two        extreme heights, maximum and minimum, and any intermediate        height, and can be adapted automatically, based on the state        that is respectively flat-folded, unfolded and expanded, and any        intermediate state of the pocket;        such that in each state of the pocket, the processing means are        offset from the side wall and the upper end portion of the        pocket, while being adjacent to its lower end portion.

In a first embodiment, the protective means are rigid andnon-deformable. In a second embodiment, the protective means aredeformable in height, whereby the side wall comprises at least onedeformable section between two extreme states, respectively folded andexpanded, capable of being deformed to switch from one state to theother, whereby the receptacle also comprises means that are capable ofkeeping the deformable section expanded, at least in the flat-foldedextreme state of the pocket. In this second embodiment, these means thatare capable of keeping the deformable section expanded, at least in theflat-folded extreme state of the pocket, are either integrated in theside wall of the protective means or separate from it.

According to one embodiment, the protective means are arranged to form ahead for introducing at least one product into the receptacle. In thiscase, the protective means that form an introduction head comprise atleast one opening for introducing said at least one product that isprovided in the upper end portion of the protective means and removablesealing means of said opening that are capable of ensuring its closingand its opening, such as a plug or a membrane. In addition, theintroduction head can, in one embodiment, comprise means for removableconnection of the receptacle to an aseptic transfer device.

According to one embodiment, at least one opening is provided in thereceptacle for introducing at least one product and/or for draining thecontents, provided in the pocket, from the receptacle, in particular inthe lower end portion.

According to one embodiment, a pocket that is equipped on the insidewith a rigid plate is provided on its lower end portion.

According to one characteristic, the protective means ensure incombination the protective function of the pocket and processing meansand a guiding function of the pocket when, the filling opening of thereceptacle being open, at least one product is gradually introduced intothe receptacle, whereas the pocket simultaneously expands upward.

According to one embodiment, the processing means and the protectivemeans are dissociated structurally from one another, being separate fromone another and without direct contact with one another, whereby theperipheral portion of the inner space of the protective means aroundprocessing means form a protective chamber that extends laterally and onthe top between the processing means and the side wall and the upper endportion of the protective means.

According to one embodiment, the processing means have a portion insidethe pocket that, in the flat-folded state of the pocket, essentiallyoccupies the inner space of the protective means. According to oneembodiment, the processing means have a portion inside the pocket that,in the expanded state of the pocket, is essentially integral within theinner space of the pocket, the height, minimum here, of the protectivechamber being zero.

According to one embodiment, the processing means have a portion insidethe carried pocket, if necessary with the possibility of relativemovement, by the inside surface of the lower end portion of the pocketor by a rigid plate with which the lower end portion of the pocket isequipped on the inside.

According to one characteristic, the receptacle comprises means that arecapable of participating in its preservation in a container, whereby thepocket contains the desired amount of at least one product. According toone embodiment, such means are integrated or combined with protectivemeans.

According to a particular embodiment, the processing means are mixingmeans, whereby the receptacle comprises at least a first introductionopening in the receptacle of a first portion of at least one productthat is made on the pocket, in particular adjacent to its lower endportion, and at least a second introduction opening of a second portionof at least one product that is provided in the upper end portion of theprotective means. The receptacle is then a mixing receptacle.

According to a second aspect, the object of the invention is a devicefor processing at least one biopharmaceutical product that comprises areceptacle as was just described and a rigid container that is capableof accommodating the receptacle whose pocket is in the flat-foldedstate, in the expanded state, or in an intermediate state, and capableof allowing the pocket to be deformed to switch from one state to theother, and of guiding the pocket, in particular its flexible side wall,so that the pocket is expanded in volume by having an additional volumeof that of the container, when the at least one product is introducedinto the receptacle.

According to another aspect, the object of the invention is a processfor the implementation of such a processing device, in which:

-   -   There are a receptacle and a container that constitute the        processing device, and the pocket of the receptacle is placed in        the flat-folded state in the bottom of the container;    -   An opening for introducing a product from the receptacle being        open, the at least one product is gradually introduced into the        receptacle and simultaneously the pocket is allowed to expand        upward and to be expanded in volume by the container, the inner        space of the pocket, of increasing volume, accommodating at        least one product; this stage is continued until having        introduced into the container the desired amount of at least one        product;    -   During this stage, the protective means are allowed to move        upward, being entrained by the movement of the upper end portion        of the pocket;    -   During this stage, the height of the protective chamber is        allowed to decrease starting from the maximum extreme height and        automatically adapts based on the state of the pocket until the        pocket is in the unfolded and expanded state or any intermediate        state based on the amount of product that is introduced into the        receptacle, such that in all the states of the pocket, the        processing means are offset from the side wall and the upper end        portion of the pocket, while being adjacent to is lower end        portion;    -   The processing means of at least one product that is in the        receptacle are implemented.

According to the embodiments, the implementation of the processing meansof at least one product that is in the receptacle is begun before, atthe time of, or after the introduction of the desired amount of at leastone product into the receptacle.

According to a particular application with mixing:

-   -   There is a mixing receptacle of which at least the second        opening is sealed;    -   The pocket of the receptacle is placed in the flat-folded state        in the bottom of the container;    -   A first portion of at least one product is introduced into the        mixing receptacle via at least a first introduction opening that        is open for this purpose;    -   And a second portion of at least one product is introduced into        the receptacle by at least a second introduction opening that is        open for this purpose.

According to the embodiments of this mixing process, the mixing meansare implemented while at least a second introduction opening is open orclosed.

According to one embodiment, made possible by the invention, the mixingmeans are implemented until the pocket is completely or essentiallycompletely drained.

Several embodiments of the invention are now described using drawings,in which:

FIG. 1 is a diagrammatic axial cutaway view of a first embodiment of aprocessing device—here a mixing device—that has a receptacle with rigidand non-deformable protective means, whereby the mixing receptacle,whose pocket is in the flat-folded extreme state, comprises a head forintroducing at least one product that has an opening and sealing meansthat close the receptacle;

FIG. 2 is a diagrammatic axial cutaway view of the mixing receptacle ofFIG. 1 that is provided with other sealing means;

FIG. 3 is a diagrammatic axial cutaway view of the mixing device of FIG.1, whereby the pocket is in the expanded extreme state;

FIG. 4 is a diagrammatic axial cutaway view of a second embodiment ofthe receptacle, with deformable protective means, whereby the processingreceptacle—here a mixing receptacle—whose pocket is in the flat-foldedextreme state, comprises a head for introducing at least one product,having an opening and sealing means that close the receptacle; and

FIG. 5 is a diagrammatic axial cutaway view of the receptacle of FIG. 4,whereby the pocket is in the expanded extreme state.

A device 1 for processing at least one biopharmaceutical productcomprises a processing receptacle 2 and a rigid container 3 that iscapable of accommodating the receptacle 2 in a removable manner.

As indicated above, “biopharmaceutical product” is defined as one (ormore) product(s) obtained from biotechnology—culture media, cellularcultures, buffer solutions, artificial nutrition liquids, blood productsand derivatives of blood products—or a pharmaceutical product or moregenerally a product that is designed to be used in the medical field.

Such a product is in liquid, pasty or powder form, in one or morephases, homogeneous or not.

Of course, the invention also applies to products other thanbiopharmaceutical products, according to the definition that was justgiven, but which is subject to analogous requirements relative to theirprocessing.

As indicated above, “processing” is defined as any action on thebiopharmaceutical product or that relates to this product and thatinvolves a contact with the product.

In the particular embodiment that is described below, such a processingis mixing.

In other embodiments, the processing is aeration, filtration, andmeasurement, whereby this list is not exhaustive.

In any case, processing means 4 that are appropriate for the desiredaction are implemented.

For example, the means 4 comprise an inner active portion 5, rigidwithin its unit, and, as appropriate, deformable or not. Such an inneractive portion 5 is, for example, a propeller in the case of mixing, anaerator in the case of aeration, a filter in the case of filtration, anda probe in the case of measuring, whereby this list is furthermore notexhaustive.

In the case where the processing is the measuring, the latter is donefor various purposes: monitoring of such a parameter that relates to thebiopharmaceutical product, control of the processing, . . . .

The receptacle 2 comprises, in addition to the processing means 4, apocket 6 and protective means 7 that ensure a first protective functionof the pocket 6 and processing means 4.

In the embodiment that is shown and described, the container 3 has ageneral parallelepipedic shape, in particular cubic or approximatelycubic, having a bottom 8, a side wall 9 that comprises four panels andan opening 10 that is opposite to the bottom 8, limited by a collarreturn 10 a of the side wall 9. It is understood that the container 3can have another shape, if necessary.

In the standard position in which the container 3 can be used, thebottom 8 extends horizontally in the lower portion; the side wall 9extends vertically, and the opening 10 is placed in the upper portion atthe base of the bottom 8. In contrast, the side wall 9 can comprise anaccess door and the bottom 8 and/or the side wall of the openings orpassages of devices that are connected to the receptacle 2 such asconnections.

The words “horizontal,” “lower,” “vertical,” “upper,” like the words“height,” “top,” and “bottom,” refer to the processing device 1, to thereceptacle 2, and to the container 3 that are in their standard positionin which they can be used. Nevertheless, it is well understood that theycan be placed in another position, in other circumstances.

It is also understood that the words “horizontal” and “vertical” pertainto both the respective exactly horizontal and vertical positions andthose that are approximately so, without it being necessary to sospecify expressly.

The pocket 6 is now described more particularly.

The pocket 6 comprises a flexible side wall 11, a flat lower end portion12, and an upper end portion 13 that delimits an inner space 14 that isdesigned to accommodate the at least one product.

When, in the container 3, the pocket 6 is expanded and expanded involume, it has, in the embodiment shown and described, a generalparallelepipedic shape, in particular cubic or approximately cubic, likethe container 3, with a side wall 11 that is arranged vertically, alower end part 12 that is arranged horizontally and an upper end part 13that is itself also arranged horizontally or more or less inclined inthe form of a roof. It is understood that the pocket 6 can have anothershape, if necessary, corresponding to that of the container 3.

The upper end portion 13 comprises one or more passages or openings 15.In the embodiment that is shown and described, a single passage 15 thatis located in the median portion of the upper end portion 13, which hasa general collar or ring shape, is provided.

Such a pocket 6 can have a volume that exceeds 50 l and can reach 3,000l. It can have a length, a width, and a height, according to the volume,of between about 30 and close to 150 centimeters.

In one embodiment, the side wall 11, the lower end portion 12, and theupper end portion 13 of the pocket 6 are produced integrally andentirely of plastic, starting from a rather thin sheet material in orderto have the required flexibility. This material is selected based on thecontents that the pocket is designed to accommodate, and, in particular,it is biocompatible with the biopharmaceutical products that arereceived, capable of sterilization and impermeable to gases.

Typically, the constituent material of the pocket 6 is such that thepocket 6 is able to be embrittled, perforated or torn in the case ofinterference with something rigid that has angles, corners, points, orsharp edges, which can be the case of the rigid active inner portion 5of the processing means 4.

Symmetrically, this rigid active inner portion 5, if it comprisesangles, corners, points, or sharp edges, can be altered more or lesssignificantly, for example deformed or moved or else wedged, in the caseof interference with something rigid or in the case of an impact,whereby the constituent material of the pocket 6 is not capable byitself of protecting it adequately.

The flexible side wall 11 is such that the pocket 6 can be in twoextreme states, namely a flat-folded state (FIGS. 1, 2 and 4), and anexpanded state (FIGS. 3 and 5). The pocket 6 can also be found in anyintermediate state between the two extreme states, namely partiallyexpanded. Further, the pocket 6, more particularly the side wall 11, canbe deformed for switching from one state to the other, in particularwhen it is filled or when it is drained.

Analogous states of the receptacle 2 that incorporates the pocket 6correspond to the folded, expanded, and intermediate states of thepocket 6.

In the folded state, the side wall 11 is folded on itself in a more orless uniform manner like an accordion, whereby the upper end portion 13rests on or is located in the immediate vicinity of the lower endportion 12, which is flat. The inner space 14 then has minimum volume,even zero or almost zero.

In the expanded state, the side wall 11 extends vertically in aprismatic or cylindrical manner, whereby the upper end portion 13 isoffset in height relative to the lower end portion 12, which is flat.The inner space 14 then has maximum volume.

The flexibility of the side wall 11 is such that in the absence ofstress, in particular due to the presence of contents in the pocket 6,itself placed in the container 3, the pocket 6 is in the folded state ortends toward this state.

The pocket 6, more generally the device 1, has a vertical axis 16,around which the side wall 11 is located and perpendicular to which thelower end portion 12 is arranged.

The height in question is counted along the axis 16.

In the embodiment that is shown and described, a rigid plate 17 that isarranged in the pocket 6 on the inner surface of its lower end portion12 is provided.

In the embodiment that is shown and described, a first opening 18 forintroducing a first portion of at least one product that is to be mixedinto the pocket 6 (and therefore the receptacle 2) is provided on thepocket 6.

This first opening 18 is adjacent to the lower end portion 12, forexample more or less laterally. If a rigid plate 17 is provided, and ifthe opening 18 is opposite the latter, the opening 18 is also providedin the rigid plate 17.

Structurally and functionally, an intake pipe 19 of the first portion ofat least one product that is to be mixed can be connected to the opening18, forming part of the intake means (pump, for example).

Of course, there can be provided not one, but several openings 18.

Further, at least one opening 18 a for draining the contents from thepocket 6 (and therefore from the receptacle 2) is provided. Thisdraining opening is itself adjacent to the lower end portion 12. It mayor may not be in common with the opening 18 and be connected to adrainpipe 19 a, which may or may not be the intake pipe 19, forming partof the draining means.

The processing means 4, in the type of mixing, will now be describedmore particularly in the embodiment that is shown and described.

As indicated, the means 4 comprise an inner active portion 5, rigid inits entirety and, as appropriate, deformable or not. This inner activeportion 5 has a certain height H1 that is counted along the axis 16. Itis arranged inside the receptacle 2. More specifically, the inner activeportion 5 is adjacent to the lower end portion 12 of the pocket 6.“Adjacent” is defined as the fact that the inner active portion 5 is on(in contact with) the inner surface of the lower end portion 12, theupper inner surface of the rigid plate 17, or close to or in thevicinity of this portion 12 or plate 17. Thus, the inner active portion5 is in contact with the contents of the pocket, even in a small amount.

According to a possible, but non-limiting embodiment, the inner activeportion 5 is connected structurally to the lower end portion 12 or therigid plate 17, for example by means of a pivoting assembly. Otherarrangements are possible.

The means 4 generally comprise other elements and devices, such asengines, control . . . arranged outside of the pocket 6 and thereceptacle 2.

The protective means 7, in the embodiment shown (processing thatconsists of a mixing), are now described more particularly.

The protective means 7, made of plastic, comprise a side wall 20, alower end portion 21, and an upper end portion 22 that define an innerspace 23 that is useful for the housing of the active inner portion 5 ofthe processing means 4, of height H2.

The inner space 23 of the protective means 7 is in communication withthe inner space 14 of the pocket 6 by means of the passage 15 that iscommon to the pocket 6 and to the means 7. The lower end portion 21 ofthe means 7 is adjacent and secured rigidly to the upper end portion 13of the pocket 6, at the periphery of the passage 15, for example bywelding, at 21 a.

In the embodiment that is shown and described, the side wall 20 isarranged for extending in the vertical direction. The lower end portion21 forms a collar that extends in a horizontal plane around and outsideof the side wall 20, so as to be able to be connected rigidly and in asealed manner to the upper end portion 13 in collar form of the pocket6.

As for the upper end portion 22, it comprises—in the embodiment of FIGS.1 to 3—a tapered section 22 a, connected downward at the upper end ofthe side wall 20 and upward to a portion that forms a port, which willbe referenced again below. In the embodiment of FIGS. 4 and 5, thissection 22 b is flat in collar shape.

According to a preferred and advantageous embodiment, the processingdevice 1 is such that, during processing, the container 3 is stationary.The pocket 6 is carried by its lower end portion 12 to the bottom 8 ofthe container 3. During the expansion of the volume of the pocket 6,resulting from which at least one product is gradually introduced intothe pocket 6, the pocket 6 expands upward, held by the outside by thecontainer 3. The upper end portion 13 of the pocket is therefore movedupward, while the lower end portion 12 remains at the same level. Whenthe pocket 6 is emptied of its contents, the pocket 6 folds downward, inparticular the upper end portion 13 is moved downward, whereby the lowerend portion 12 remains at the same level. It is in reference to thispreferred and advantageous embodiment and to these movements that thedevice 1 is described and that the expressions “upward” and “downward”should be understood in a conventional manner.

It is understood, however, that the movements are above all relative andthat it is possible to consider that the upper end portion 13 of thepocket 6 remains at the same level, while the lower end portion 12 ismoved upward or downward.

With reference being made to the preferred and advantageous embodimentdescribed above, to movements that it induces, to the meaning to begiven to the expressions “upward” and “downward,” it appears that themovement of the upper end portion 13 of the pocket 6 upward or downwardentrains a correlative movement of the protective means 7.

The arrangement of the mixing device 1 is such that the active innerportion 5 of the processing means 4 is essentially arranged in the innerspace 23 of the protective means 7 when the pocket 6 is in theflat-folded state.

The peripheral portion of the inner space 23 of the protective means 7around processing means 4, more specifically the active inner portion 5,forms a protective chamber 24, both the pocket 6 and processing means 4.The height of this protective chamber 24, counted along the axis 16, isH3.

Protection is understood as the fact, first of all, that the activeinner portion 5 is prevented from interfering with the pocket 6, inparticular the upper end portion 13, in the folded state and/or duringthe draining of the pocket 6, which prevents the constituent material ofthe pocket 6 from being embrittled, perforated or torn by the activeinner portion 5, and the fact, then, that the active inner portion 5 isprevented from interfering with something rigid or in the case ofimpact, which prevents it from being altered more or less significantly,for example deformed or moved or else wedged.

The mixing means 4 (processing) and the protective means 7 are arrangedto be independent of one another relative to their movements.

In the embodiment that is shown and described, the processing means 4and the protective means 7 are dissociated structurally from oneanother, being separate from one another and without direct contact withone another. In this case, the peripheral portion of the inner space 23of the protective means 7 around processing means 4 that form theprotective chamber 24 extends laterally (horizontally) and on the top(vertically and upward) between the processing means 4, and, on the onehand, the side wall 21, and, on the other hand, the upper end portion22, protective means 7.

In contrast, the height H3 of the protective chamber 24 is variable. Itcan be one of two extreme heights, maximum and minimum (and anyintermediate height) based on the respectively flat-folded and unfolded,expanded states (and any intermediate state) of the pocket 6. Inaddition, the height H3 of the protective chamber 24 adaptsautomatically, based on the state of the pocket 6.

The constructive arrangements that are described are such that in eachstate of the pocket 6, the mixing means 4 (processing) are offset fromthe side wall 11 and the upper end portion 13 of the pocket 6, whilebeing—and remaining—adjacent to its lower end portion 12.

In the flat-folded state of the pocket 6, the active inner portion 5 ofthe processing means 4 essentially occupies the inner space 23 of theprotective means 7.

In the deployed state of the pocket 6, the active inner portion 5 of theprocessing means 4 is essentially integral in the inner space 14—thenmaximum—of the pocket 6, whereby the height H3 of the protective chamber24 is minimum and zero.

During the refolding of the pocket 6, subsequent to its draining, theactive inner portion 5 of the processing means 4 is rehoused in theinner space 23 of the protective means 7, which allows theimplementation of the active portion, in particular its movement, up tothe end of the draining of the pocket 6.

In the particular application where the processing is a mixing, thereceptacle 2—mixing receptacle—comprises at least a second opening 25for introducing a second portion of at least one product. This at leastone second introduction opening 25 is provided in the upper end portion22 of the protective means 7, being at the top, while the firstintroduction opening 18 is on the bottom. Thus, the protective means 7form a head 26 for introducing at least one product into the receptacle2, comprising, in addition to the at least one second opening 25,removable means 27 for sealing the second opening 25.

The removable sealing means 27 of the second opening 25 are capable ofensuring its closing and its opening.

In the embodiment that is shown in FIGS. 1 and 4, the removable means 27for sealing the second opening 25 comprise a plug that is kept in placeon a collar 28 that is provided on the free edge of the upper endportion 22 that forms a port that has a general chimney shape around theopening 25, based on a suitable holding system that is removable.

In the embodiment that is shown in FIG. 2, the removable means 27 forsealing the second opening 25 comprise a membrane that is secured bygluing or welding to the free edge of the upper end portion 22 in thegeneral shape of a chimney. This membrane can be removed by peeling, inparticular using a pull tab 29.

Of course, these removable sealing means 27 do not exclude otherembodiments.

Further, the introduction head 26 can, in one embodiment, not shown,comprise removable means of the receptacle 2 for connection to anaseptic transfer device, of the type of those that comprise an aseptictransfer pocket.

Under these conditions, the mixing device 1 makes possible, according tothe embodiments, an addition of product in an aseptic or non-asepticmanner.

The protective means 7 ensure in combination not only the function ofprotection of the pocket 6 and processing means 4, described above, butalso a guiding function of the pocket 6, when, the opening 18 beingopen, the at least one product (arrow R in FIGS. 3 and 5) is graduallyintroduced into the receptacle 2, while simultaneously the pocket 6expands upward, as well as during the draining of the pocket 6.

A first embodiment of the protective means 7 is now described withreference to FIGS. 1 to 3. In this first embodiment, the protectivemeans 7—and in particular the side wall 20—are rigid and non-deformable.The protective means 7 then have a general shape that corresponds to awide prism that is terminated by a collar at the low portion, acylindrical chimney of smaller diameter in the top portion, and, betweenthe two, a tapered portion.

A second embodiment of the protective means 7 is now described withreference to FIGS. 4 and 5. In this second embodiment, the protectivemeans 7—and in particular the side wall 20—can be deformed in height.

In this second embodiment, the side wall 20 of the protective means 7comprises at least one section 30 of a deformable portion between twoextreme states, respectively flat-folded and expanded vertically, incontrast capable of being deformed to switch from one state to theother. If necessary, it is the entire side wall 20 that is deformable.

In addition to a suitable deformability of the deformable section 30,suitable means are provided that are capable of keeping the deformablesection 30 expanded, when this is desired, in particular at least in theflat-folded extreme state of the pocket and in the absence of stress.

In one embodiment, such means that are capable of keeping the deformablesection 30 expanded are integrated in the deformable section 30 and inthe side wall 20 that is of the compressible type. This is defined asthe deformable section 30 comprising peripheral ribs that in the absenceof external stress are capable of keeping the deformable sectionexpanded but that can, as a result of external compressive stress(support toward the bottom), become deformed such that the deformablesection 30 folds like an accordion.

In another embodiment, in which the deformable section 30 is flexible,the means that are capable of keeping the deformable section 30 expandedare separate from the side wall 20. They can consist of a removableoutside support, able to be carried itself by the container 3 toward itsopening 10.

Further, being designed to be arranged in the container 3, the container2 advantageously comprises means 31 that are capable of participating inits holding in the container 3, whereby the pocket 6 contains thedesired amount of at least one product.

According to one embodiment, such means 31 are integrated or connectedto protective means 7. They can consist of, for example, an outer collarthat is provided on the outer surface of the side wall 20 of theprotective means 7 toward the lower end portion 21. Such a collar 31 canthen work with a conjugated portion that is provided for this purpose inthe container 3, such as the collar return 10 a. According to oneembodiment, this conjugated portion comprises two removable crosspieces,mounted on the container 3, carried by and secured in a removable mannerto the container 3 toward its upper opening and arranged under thecollar 31 once the pocket 6 has been filled.

A processing receptacle 6 (mixing) as described above can be found in astorage situation before use. The pocket 6 that contains the activeinner portion 5 of the processing means 4 is then in the folded state.In this state, the pocket 6 has minimal outside occupied space and canbe easily stored and handled. It is understood that in this situation,the pocket 6 is closed, whereby the openings 18, 25 are sealed.

To implement the processing device 1 (mixing), such a receptacle 2 and acontainer 3 are used, whereby the two constitute the device 1. Thepocket 6 of the receptacle in the flat-folded state is placed in thecontainer 3, on the bottom 8. As indicated above, the active innerportion 5 of the processing means 4 then essentially occupies the innerspace 23 of the protective means 7 by thus being offset from the sidewall 11 and the upper end portion 13 of the pocket 6. The pocket 6 andthe processing means 4 are thus protected (FIGS. 1, 2 and 4). Theprotective chamber 24 is then maximal.

The first opening 18 for introducing into the pocket 6 a first portionof at least one product to be mixed being open, a first portion of atleast one product is gradually introduced into the mixing receptacle 2.

Simultaneously, the pocket 6 is allowed to expand upward and to beexpanded in volume by the container 3.

The inner space 14 of the pocket 6 sees its volume increase gradually,accommodating the at least one product.

This stage is continued until having introduced the desired amount of atleast one product into the container 2.

During this stage, the protective means 7 are allowed to move upward,being driven by the movement of the upper end portion 13 of the pocket6.

Further, during this stage, and as the protective means 7 move upward,the height of the protective chamber 24 is allowed to decrease from thepreceding maximum extreme height and to adapt automatically based on thestate of the pocket 6 until the pocket 6 is in the unfolded and expandedstate—or any intermediate state—based on the amount of product that isintroduced into the pocket 6 (FIGS. 3 and 5). The active inner portion 5of the processing means 4 is then completely freed from the protectivechamber 24 to be located integrally in the inner space 14 of the pocket6.

In the case of the second embodiment of the protective means 7, thedeformable section 30 is, in the expanded state, at least at thebeginning of the upward movement of the protective means 7. Once thepocket 6 is in the unfolded and expanded state, the deformable section30 can be compressed. This constituent arrangement makes it possible tolimit the upward occupied space of the device 1 and to house the latterintegrally or almost integrally in the container 3. If necessary, thedeformable section 30 is compressed as upward movement of the protectivemeans 7 proceeds.

In all of the states of the pocket, the active inner portion 5 of theprocessing means 4 is offset from the side wall 11 and the upper endportion 13 of the pocket 6 while being—and remaining—adjacent to itslower end portion 12. The pocket 6 and the processing means 4 thusalways remain protected by a type of permanent and modular protectionscreen between the pocket 6 and the active inner portion 5.

The process also comprises a stage in which the processing means 4 of atleast one product that is in the receptacle 2 are implemented.

In the case where the processing is a mixing, a second portion of atleast one product is introduced into the receptacle 2 by the secondintroduction opening 25 that is open for this purpose (arrow R, FIGS. 3and 5). For example, a product in the solid state is introduced, whilethe receptacle 2 contains a product in the liquid state.

According to the embodiments, the introduction of the second portion ofat least one product via the second introduction opening 25 begins whenan adequate amount of the first portion of the product is found in thepocket 6, or when the entire first portion of the product has beenintroduced into the pocket 6.

According to the embodiments, the implementation of the mixing means 4of at least one product that is found in the receptacle 2 is begunbefore, at the time of, or after the introduction of the desired amountof at least one product into the receptacle 2. And, the mixing means 4are implemented while the at least one second introduction orifice 25 isopen or closed.

As indicated above, it is understood that the movements should beconsidered as relative movements.

During the draining of the receptacle 2, the draining opening 18 a thatis provided for this purpose is opened. Contrary to the practice of theprior art, it is possible to drain the pocket 6 completely, withoutrunning the risk of tearing, using protective means 7 that form ascreen. In addition, it is possible to continue the mixing untildraining is complete, whereby the active portion 5 is protected, as hasbeen described.

The mixing process therefore also has the optional characteristic thatthe mixing means 4 are implemented until draining of the pocket 6 iscomplete or essentially complete.

1. Processing receptacle (2) for at least one biopharmaceutical product,comprising: A pocket (6) that has a flexible side wall (11), a lower endportion (12) and an upper end portion (13) that define an inner space(14) that is designed to accommodate the at least one product that canbe in two extreme states, flat-folded and expanded, and in anyintermediate state, and can be deformed to switch from one state to theother; Means (4) for processing at least one product that is containedin the receiving space (14) of the pocket (6), comprising an activeinner portion (5) of a certain height that is arranged inside thereceptacle (2); Protective means (7) of the processing means (4),comprising a side wall (20), a lower end portion (21), and an upper endportion (22) that define an inner space (23) communicating with theinner space (14) of the pocket (6), whose lower end portion (21) isadjacent and attached rigidly to the upper end portion (13) of thepocket (6), the movement of the latter upward or downward bringing abouta movement of the protective means (7), whereby the active inner portion(5) of the processing means (4) is essentially arranged in the innerspace (23) of the protective means (7) when the pocket (6) is in theflat-folded state, the peripheral portion of the inner space (23) of theprotective means (7) around processing means (4) forming a protectivechamber (24) of the pocket (6) and processing means (4); At least oneopening (18) for introducing at least one product into the receptacle(2) and/or for draining the contents from the receptacle (2);characterized in that: At least for an active inner portion (5), theprocessing means (4)—mixing element, sensor, tube, aerating element,etc.—are arranged inside the pocket (6) by being adjacent to its lowerend portion (12); The processing means (4) and the protective means (7)are arranged to be independent from one another relative to theirmovements; The variable height of the protective chamber (24) can be oneof two extreme heights, maximum and minimum, and any intermediateheight, and can be adapted automatically, based on the state that isrespectively flat-folded, unfolded and expanded, and any intermediatestate of the pocket (6); Such that in each state of the pocket (6), theprocessing means (4) are offset from the side wall (11) and the upperend portion (12) of the pocket (6), while being adjacent to its lowerend portion (13).
 2. Processing receptacle (2) according to claim 1,wherein the protective means (7) are rigid and non-deformable. 3.Processing receptacle (2) according to claim 1, wherein the protectivemeans (7) are deformable in height, whereby the side wall (20) comprisesat least one deformable section (30) between two extreme states,respectively folded and expanded, capable of being deformed to switchfrom one state to the other, whereby the receptacle (2) also comprisesmeans that are capable of keeping the deformable section (30) expanded,at least in the flat-folded extreme state of the pocket (6). 4.Processing receptacle (2) according to claim 3, wherein the means thatare capable of keeping the deformable section (30) expanded, at least inthe flat-folded extreme state of the pocket (6), are integrated in theside wall (20) of the protective means (7) or separate therefrom. 5.Processing receptacle (2) according to claim 1, wherein the protectivemeans (7) are arranged to form a head (26) for introducing at least oneproduct into the receptacle (2).
 6. Processing receptacle (2) accordingto claim 5, wherein the protective means (7) that form a head (26) forintroducing at least one product into the receptacle (2) comprise atleast one opening (25) for introducing said at least one product that isprovided in the upper end portion (22) of the protective means (7) andremovable sealing means of said opening that are capable of ensuring itsclosing and its opening.
 7. Processing receptacle (2) according to claim6, wherein the removable sealing means (27) of said introduction opening(25) of said at least one product are a plug or a membrane. 8.Processing receptacle (2) according to claim 5, wherein the head (26)for introducing at least one product into the receptacle (2) comprisesmeans for removable connection of the receptacle (2) to an aseptictransfer device.
 9. Processing receptacle (2) according to claim 1,characterized by at least one opening (18) for introducing at least oneproduct into the receptacle (2) and/or for draining the contents,provided in the pocket (6), from the receptacle (2).
 10. Processingreceptacle (2) according to claim 9, characterized by an opening (18)for introducing at least one product into the receptacle (2) and/or fordraining the contents, provided in the lower end portion (12) of thepocket (6), from the receptacle (6).
 11. Processing receptacle (2)according to claim 1, characterized by a pocket (6) that is equipped onthe inside with a rigid plate (17) on its lower end portion (12). 12.Processing receptacle (2) according to claim 1, characterized byprotective means (7) of processing means (4), ensuring in combinationthe protective function of the pocket (6) and processing means (4) and aguiding function of the pocket (6), when, the opening (18) being open,the at least one product is gradually introduced into the receptacle(2), while simultaneously the pocket (6) expands upward.
 13. Processingreceptacle (2) according to claim 1, characterized by processing means(4) and protective means (7) that are dissociated structurally from oneanother, being separate from one another and without direct contactbetween them, whereby the peripheral portion of the inner space (23) ofthe protective means (7) around processing means (4) forms a protectivechamber (24) that extends laterally and on the top between theprocessing means (4) and the side wall (20) and the upper end portion(22) of the protective means (7).
 14. Processing receptacle (2)according to claim 1, characterized by processing means (4) that have anactive portion (5) inside the pocket (6) that, in the flat-folded stateof the pocket (6), essentially occupies the inner space (23) of theprotective means (7).
 15. Processing receptacle (2) according to claim1, characterized by processing means (4) that have an active portion (5)inside the pocket (6) that, in the expanded state of the pocket (6), isessentially integral in the inner space (14) of the pocket (6), wherebythe minimum height of the protective chamber (24) is zero. 16.Processing receptacle (2) according to claim 1, characterized byprocessing means (4) that have an active portion (5) inside the carriedpocket (6), if necessary with the possibility of relative movement, bythe inner surface of the lower end portion (12) of the pocket (6) or bya rigid plate (17) that equips the lower end portion (12) of the pocket(6) on the inside.
 17. Processing receptacle (2) according to claim 1,wherein it comprises means (31) that are capable of participating in itsholding in a container (3), whereby the pocket (6) contains the desiredamount of at least one product.
 18. Processing receptacle (2) accordingto claim 17, wherein the means (31) that are capable of participating inits holding in a container (3), whereby the pocket (6) contains thedesired amount of at least one product, are integrated or connected toprotective means (7).
 19. Mixing receptacle (2), wherein it consists ofa receptacle (2) according to claim 1, wherein the processing means (4)are mixing means, whereby the receptacle (2) comprises at least a firstopening (18) for introducing a first portion of at least one productthat is provided in the pocket (6) into the receptacle (2), inparticular adjacent to its lower end portion (12), and at least a secondopening (25) for introducing a second portion of at least one productthat is provided in the upper end portion (22) of the protective means(7).
 20. Device (1) for processing at least one biopharmaceuticalproduct, comprising a receptacle (2) according to claim 17, and a rigidcontainer (3) that is capable of accommodating the receptacle (2) whosepocket (6) is in the flat-folded state, in the expanded state, or in anintermediate state, to allow the pocket (6) to be deformed in order toswitch from one state to the other, and to guide the pocket (6), inparticular its flexible side wall (11), so that the pocket (6) isexpanded in volume, with an additional volume of that of the container(3), when the at least one product is introduced into the receptacle(2).
 21. Process for implementing a processing device (1) according toclaim 20, wherein: There are a receptacle (2) and a container (3) thatconstitute the processing device (1), and the pocket (6) of thereceptacle is placed in the flat-folded state on the bottom (8) in thecontainer (3); An opening (18) for introducing a product of thereceptacle (2) being open, at least one product is gradually introducedinto the receptacle (2) and simultaneously the pocket (6) is allowed toexpand upward and to be expanded in volume by the container (3), theinner space (14) of the pocket (6), of increasing volume, accommodatingthe at least one product; this stage is continued until havingintroduced the desired amount of at least one product into thereceptacle (2); During this stage, the protective means (7) are allowedto move upward, being entrained by the movement of the upper end portion(13) of the pocket (6); During this stage, the height of the protectivechamber (24) is allowed to decrease starting from the maximum extremeheight and automatically adapting based on the state of the pocket (6)until the pocket (6) is in the unfolded and expanded state or anyintermediate state, based on the amount of product that is introducedinto the receptacle (2), such that in all of the states of the pocket(6), the processing means (4) are offset from the side wall (11) and theupper end portion (13) of the pocket (6), while being adjacent to islower end portion (12); The processing means (4) of at least one productthat is in the receptacle (2) are implemented.
 22. Process according toclaim 21, wherein: the implementation of the processing means (4) of atleast one product that is found in the receptacle (2) is begun before,at the time of, or after the introduction of the desired amount of atleast one product into the receptacle (2).
 23. Mixing process, whereinthe process is implemented according to claim 21, wherein: There is amixing receptacle (2) comprising at least a first opening (18) forintroducing a first portion of at least one product that is provided inthe pocket (6) into the receptacle (2), in particular adjacent to itslower end portion (12), and at least a second opening (25) forintroducing a second portion of at least one product that is provided inthe upper end portion (22) of the protective means (7), the at leastsecond opening (25) being sealed; The pocket (6) of the receptacle (2)is placed in the flat-folded state on the bottom (8) in the container(3); A first portion of at least one product is introduced into themixing receptacle (2) via at least a first introduction opening (18)that is open for this purpose; And a second portion of at least oneproduct is introduced into the receptacle (2) via the secondintroduction opening (25) that is open for this purpose.
 24. Mixingprocess according to claim 23, wherein mixing means (4) are implemented,while the at least one second introduction opening (25) is open orclosed.
 25. Mixing process according to claim 23, wherein the mixingmeans (4) are implemented until the pocket (6) is completely oressentially completely drained.